Protocol Number: 00-D-0200
Three groups of patients will participate in this study: 1) dental patients undergoing removal of impacted third molars (wisdom teeth); 2) patients with complex regional pain syndrome type 1, or CRPS-I (also called reflex sympathetic dystrophy); and 3) patients with complex regional pain syndrome type 2, or CRPS-II. CRPS-I is pain that develops after relatively minor injury to an arm or leg, but lasts much longer and is much more severe than would normally be expected. CRPS-II is pain resulting from injury to a large nerve. Candidates will have a history and physical examination, blood tests, electrocardiogram and, for dental patients, oral examination and dental X-rays to confirm the need for third molar extraction. Participants will undergo the following tests and procedures: Dental patients will have oral surgery to remove their upper and lower third molars on one side. Before surgery, they will be given two injections: a local anesthetic (lidocaine) and a sedative (midazolam). They will also receive neurotropin tablets or placebo-look-alike tablets with no active medicine-1 hour before surgery, several hours after surgery and 4 times a day for 2 days. If needed, patients may also take a standard painkiller that will be supplied to them. After 2 days they will be given a different painkiller to use for the rest of the recovery period. After at least one week, patients will return for removal of the third molars on the other side and will repeat the drug regimen described above, except patients who received placebo for the first surgery will receive neurotropin for the second surgery, and vice versa. Neither the patients nor the doctors will know who received placebo and who received neurotropin for each surgery until the study is over. Patients with CRPS I and II will receive an individualized regimen of physical therapy and standard treatment to control their pain. In addition, they will receive neurotropin or placebo tablets for 5 weeks, then no trial medicine for at least 1 week, and then the other trial drug for the next 5 weeks. That is, patients who took placebo the first 5 weeks will take neutropin the second 5 weeks and vice versa. Neither the patients nor the doctors will know who received which drug during the two intervals until the study is over. Patients will complete questionnaires about their pain, quality of life, and ability to perform daily living activities. They will have various tests to measure pain (such as sensitivity to heat and cold, to an electric current, to a mild pin prick, etc.); to provide information about changes in their condition (such as tests of range of motion of joints and limb size); to measure blood circulation and sweating in the arm or leg (such as measurements of blood flow to the limb, skin temperature, and sweat production), and other procedures.
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